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Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Recruiting
18-65 years
Female
Phase 2/3

Overview

Metformin is a widely used anti-diabetic drug. Several studies have pointed out a potentially beneficial effect of metformin therapy in diabetic cancer patients. Several studies are investigating the anti-tumor effect of metformin in early breast cancer. However, the enhancing effect of metformin on anti-tumor immunity has only been demonstrated in animal models. This study examines the immune effect of metformin in breast cancer patients treated with preoperative chemotherapy.

Eligibility

Inclusion Criteria:

  • Histologically proven breast carcinoma.
  • American Society of Anesthesiology (ASA) score I-II.
  • Candidate for neoadjuvant chemotherapy as per hospital's protocol.
  • Clinically measurable tumor.
  • No evidence of distant metastasis.
  • Normal renal and liver functions.
  • Non-diabetics.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Metastatic breast cancer patients.
  • Patients with hepatic impairment.
  • Patients with renal impairment.
  • Diabetics.
  • Patients unwilling to participate or withdrawing from the trial.
  • Psychological/ mental impairment.

Study details
    Breast Cancer
    Breast Cancer

NCT04387630

Mansoura University

16 February 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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